FDA Withdraws Approval for ZULRESSO Following Sage Therapeutics' Request
March 14, 2025
March 14, 2025
WASHINGTON, March 14 (TNSFR) -- The Food and Drug Administration (FDA) has announced the withdrawal of approval for ZULRESSO (brexanolone) solution, 100 mg/20 mL, following a request from its manufacturer, Sage Therapeutics, Inc.
The company, headquartered in Cambridge, Massachusetts, informed the agency that the drug is no longer being marketed and requested the withdrawal of its new drug application (NDA 211371). The FDA confirmed that the approval will be officially withdrawn as . . .
The company, headquartered in Cambridge, Massachusetts, informed the agency that the drug is no longer being marketed and requested the withdrawal of its new drug application (NDA 211371). The FDA confirmed that the approval will be officially withdrawn as . . .